Second Haplo-transplantation for Graft Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorPeking University People's Hospital
About this trial
Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.); 2. Graft failure after the first haploidentical stem cell transplantation; 3. Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.
Disqualifiers
1. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score>2; 5. Expected life time<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,
Trial design
Design model
Single group
Treatments tested in this trial
second allogeneic stem cell transplantation
Other intervention1. Change another donor if possible 2. Conditioning regimen: fludarabine (30mg/m2/day, days -6 to -2 ), cyclophosphamide (1g/m2/day, days -5 to -4) 3. GVHD prophylaxis: cyclosporine A (concentration 150-250ng/ml), mycophenolate mofetil (0.5g bid -3d to neutrophil engraftment)+anti CD25 monoAb (20mg -1d, +4d, +15d)
Treatment groups
34 Participants
are divided into 1 treatment groupGroup A: intervention armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Engraftment of neutrophils
Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL.
Time frame
28 days after second transplantationSecondary outcomes
1
Engraftment of Platelet
Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10\^9/L in the absence of platelet transfusion
Time frame
100 days after second transplantation2
TRM at 28 day
treatment-related mortality (TRM) was defined as death from any cause other than relapse
Time frame
28 days after second transplantation3
TRM at 100 day
treatment-related mortality (TRM) was defined as death from any cause other than relapse
Time frame
100 days after second transplantation4
GVHD
Both acute and chronic GVHD was diagnosed and graded according to international criteria.
Time frame
Participants will be followed for an expected average of 1 yearSponsors and contacts
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Peking University People's Hospital
Lead sponsor
The First Affiliated Hospital of Soochow University
Collaborator
Ruijin Hospital
Collaborator
Zhejiang University
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Shandong Provincial Hospital
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
Hebei Yanda Ludaopei Hospital
Collaborator
Tongji Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Peking University First Hospital
Collaborator
Jiangsu Provincial People's Hospital
Collaborator
Shengjing Hospital
Collaborator
Xinqiao Hospital of Chongqing
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Anhui Provincial Hospital
Collaborator
Source ClinicalTrials.gov